People with severe allergies should consult doctor prior to COVID-19 vaccination

INDIANAPOLIS (WISH) — British investigators are looking into if Pfizer’s vaccine is linked to allergic reactions that occurred within a day after two health care workers were given the shot. 

While many trial participants have recovered from side effects, health officials are warning anyone with a history of serious allergic reactions should not get the vaccine. 

News 8 spoke with Dr. Shaun Grannis, vice president of data and analytics at the Regenstrief Institute, who agrees. 

Gillis: The Pfizer COVID-19 vaccine was just given its first doses to some candidates in the United Kingdom. Today there are reports that there have been side effects, specifically in two healthcare workers. These individuals both use epi pens and they experienced an anaphylactoid reaction, which can be really dangerous. So, this leads us to some questions about this vaccine. How did we miss this in the clinical trial? How did we miss that this could have been a side effect of the Pfizer vaccine?

Grannis: Well, I’m not sure that we missed it. This trial has over 44,000 people in it. They look for these adverse events. There were allergic reactions. Not anaphylactic reactions or anaphylactoid reactions like we’re seeing here, but in .6 percent of people who got the vaccine there were allergic reactions and in .5 percent of the placebo group there were allergic reactions reported. So, that’s a .1 percent increase among the vaccine group. It’s a small number and there is a lot of uncertainty around that number. 

We always know there are allergies associated with vaccines. They are typically very mild and very rare and the fact that these two people carried epi pens on a regular basis tells you they have a history of severe or a significant risk of severe anaphylactic response. We always…there is always a caution on vaccines that if you are allergic to any of the ingredients in the vaccine or if you have a prior history of severe anaphylactic reactions you should be cautioned against taking the vaccine.

I don’t know if we have all the details on why or how these individuals were cleared for the vaccine, but what I think is important for people to understand is that very often we hear about allergic reactions and in healthcare we see a lot of folks say I have a food allergy so I’m not going to take the vaccine. And the reality is almost everybody has some sort of allergy to something. Typically it’s very mild and is not a big problem and it doesn’t affect their life. The fact that you might have a food allergy does not mean you shouldn’t take the vaccine.

But we always caution that anybody who has severe prior allergic reactions–like apparently these two people did–there needs to be a lot of caution around that and so we will continue to advise people that if you have had a history of severe allergic reactions…and by severe we mean you have to carry around an epi pen to treat severe reactions or had to be hospitalized or have been to the emergency room because of that…those are reasons to be concerned. Otherwise, it’s not a big deal and I guarantee you there are always cautions around these vaccines as people contemplate taking them. 

Gillis: There were two individuals who just happened to have an allergic reaction and it just happened to be that they both carry epi pens. I mean, could this just be a coincidence that they had this sort of reaction? Because the numbers are so big. Could something else have happened and this was just coincidental? Or can we directly link this back to the vaccine?

Grannis: Sure. It sounds like it was related to the vaccine. But we’re sort of in the speculation space here because not everything has come out. So, I don’t know all the details around this. But what I do understand is that these people had to carry epi pens, which tells you something significant about them. 

We do often uncover rare, smaller reactions that might not have been picked up in the initial trial. In fact, the United States has something called the vaccine adverse event reporting system that’s been in place for years to exactly capture these issues. And so I think the COVID-19 vaccines will be the most closely monitored vaccine deployment in human history. So, I think we’re going to be watching this one closely and I think we need to continue watching. But again, the typical precautions are in place here: you have a significant history of anaphylactic reaction or if you have any allergic reactions to the ingredients of the vaccine you should be talking to your healthcare provider about your eligibility.

Gillis: So, this has been true for vaccines in the past. This isn’t specific to COVID-19 that someone with an allergy could have some sort of adverse or mild reaction to the vaccine. 

Grannis: Right. The known medical knowledge is in play here. We do know that people who have increased risk for anaphylaxis…anaphylactic reactions are a very specific type of response and they impact a very small percentage of the people. But people who’ve been impacted know they’ve been impacted because they’ve experienced some significant clinical outcome or event that requires them to carry that pen and to be aware and alert. So, again we’re always cautious. People could develop a mild reaction to a vaccine, but for the vast majority of people…they enrolled 44,000 people in the study and 42,000 people got the second vaccine. So, that goes to show safety and the ability for this to be tolerated by a very large population. 

To be clear though…in the research study–and I think this is important–most people with a prior history of anaphylactic response or any known allergies to the ingredients in the vaccine were excluded from the trial. So, if they are excluded from the trial, they probably should be excluded from taking the vaccine. So that’s some guidance. And again, that guidance is not unique to the COVID-19 vaccine. 

Gillis: Right. And that raises a really interesting point because we are slated to get FDA approval and have this roll out to the U.S. after the FDA convenes and we are expected to distribute millions of doses. This has been tested on 44,000 people…this Pfizer vaccine. But it will essentially be going to millions in the U.S. and billions of people around the world. The way in which this is going to be distributed–these science organizations along with the CDC–to the frontline care workers followed by our vulnerable populations. Well, our vulnerable populations carry many things…many comorbidities that could potentially elicit an adverse reaction. So, it raises the question…if someone has an allergy and has an adverse reaction…well, we know what to do with that allergy. In this instance we have our epi pen and we know what to do when we experience something or some sort of adverse effect. Luckily, these people knew right away what was happening after they took the vaccine and the events that followed.

What are your thoughts regarding the way in which this is going to be distributed? Because, as you had mentioned, people with this type of allergy were not included in the study. They may have been dismissed because of this pre-existing allergy to the vaccine. But what about people who have diabetes or hypertension or certain cancers? What are your thoughts on the larger issue on how this is going to be distributed?

Grannis: Sure. These questions apply to any vaccine trial that occurs when any new vaccine is developed. We’ve looked very closely at the patients, the selection process for the types of patients that go into the trial. They are chosen in an effort to represent as broad a population as possible. So, they are designed to as much as possible to detect even infrequent outcomes. But it’s not possible to capture everything. But what we do know about the safety of this vaccine is…regardless of age, race or gender…we didn’t see any adverse side effects. 

And I think it’s going to be very important because every person’s health history, circumstance is different…to have a conversation if you have any concerns about your eligibility for the vaccine to talk with your healthcare provider and make that determination. 

For the vast majority of the population, this vaccine is safe. It will be safe and we’ll continue to monitor its effectiveness. 

Gillis: We have 30 more seconds. What else would you like to tell us? What should we expect? Should we be hopeful?

Grannis: I do think we should be hopeful. We’ve been waiting for vaccines for some time. The study data on these vaccines are out there. They have passed and are under review for their safety and efficacy. All of the data that I’ve seen suggests that there is a reasonable safety profile and in fact some investigators and individuals who have seen the full data said I’d give this vaccine an A+ for safety. I think we can be hopeful and confident in the process that the vaccines are going through to be tested and validated as all vaccines before them have been. 

News 8’s medical reporter, Dr. Mary Elizabeth Gillis, D.Ed., is a classically trained medical physiologist and biobehavioral research scientist. She has been a health, medical and science reporter for over 5 years. Her work has been featured in national media outlets. You can follow her on Instagram @reportergillis and Facebook @DrMaryGillis.